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Completed

NCT Number: NCT06388824

The Effect of Esketamine on Sleep Disturbance

To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University General Hospital

Tianjin, 300052, China

About this study

Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.

Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older with sleep disturbance;
  • American Society of Anesthesiologists physical status I-III;
  • A gestational age below 12 weeks;
  • Elective surgery is proposed;
  • BMI of 19-30 kg/m2;
  • Patients who agreed to enroll in this study voluntarily

Exclusion criteria

  • Any contraindications to ketamine or esketamine;
  • Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
  • Respiratory insufficiency, respiratory failure;
  • Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
  • BMI<18 kg/m2 or BMI>30kg/m2;
  • Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;
  • Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Treatment and study plan

normal saline

Drug

Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery

Other names: sodium chloride injection

Esketamine

Drug

Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery

Other names: Esketamine Hydrochloride Injection

Primary outcomes

  1. The incidence of sleep disturbance on the first night after surgery

    Time frame: the first night after surgery

    Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the first night after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.

Secondary outcomes

  1. The incidence of sleep disturbance on the second and third postoperative nights

    Time frame: the second and third nights after surgery

    Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the second and third day after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the second and third postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.

  2. The incidence of sleep disturbance on the seventh postoperative nights

    Time frame: the seventh night after surgery

    Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the seventh day after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the seventh postoperative nights to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.

  3. Postoperative anxiety

    Time frame: 1 day before surgery, 1, 2, 3 and 7 days after surgery

    Patients completed the anxiety rating scales (HADS-A,Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery. HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety. And we asked the patients to fill out this questionnaire on the 1, 2, 3 and 7 days after surgery again to evaluate the changes in anxiety. We recorded HADS-A scores as statistical indicators.

  4. Postoperative depression

    Time frame: 1 day before surgery, 1, 2, 3 and 7 days after surgery

    Patients completed the depression rating scales (HADS-D,Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery. HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression. And we asked the patients to fill out this questionnaire on the 1, 2, 3 and 7 days after surgery again to evaluate the changes in depression. We recorded HADS-D scores as statistical indicators.

  5. Pain intensity

    Time frame: 1 hour after surgery, 1, 2, 3 and 7 days after surgery

    The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.

  6. Adverse event

    Time frame: Within 1 hour after surgery, within 1 day after surgery

    All kinds of adverse events (nausea, vomiting, tachycardia, hypertension, somnolence, dizziness, hallucination, diplopia, etc) occurred in patients were recorded

  7. preoperative hemoglobin concentration

    Time frame: the day before surgery

    Hemoglobin concentration in venous blood was measured.

  8. Human Chorionic Gonadotropin level

    Time frame: within one week before surgery, within one week after surgery

    Human Chorionic Gonadotropin (HCG) in venous blood was measured.

  9. The incidence of sleep disturbance on the day before surgery

    Time frame: the day before surgery

    Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the day before surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire on the day before surgery to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.

  10. The incidence of sleep disturbance before surgery

    Time frame: the day before surgery

    Patients completed the sleep quality scale (PSQI, Pittsburgh sleep quality index) on the day before surgery. The PSQI has a total of 24 items(Including 19 self-evaluation items and 5 other evaluation items),of which the 19th self-evaluation item and 5 other self-evaluation items do not participate in scoring, while the remaining 18 self-evaluation items participate in scoring, with each item scoring 0-3 points. The total score of the scale ranges from 0 to 21 points, with a total score higher than 5 indicating poor sleep quality. We require patients to fill out this questionnaire one day before surgery to evaluate whether they have had sleep disorders in the past month.We recorded PSQI scores as statistical indicators.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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